Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.

This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.

I. To evaluate the feasibility for assessing oral mucosa in vivo with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent.

II. To develop and evaluate algorithms to classify tissue as normal (including hyperkeratosis, hyperplasia, and inflammation) or abnormal (any grade of dysplasia or cancer) based on quantitative parameters extracted from the optical images.

SECONDARY OBJECTIVES:

I. To determine the percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye.

II. To identify qualitative and quantitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions.

OUTLINE:

Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (high-resolution microendoscope [HRME]) at baseline, after induction of general anesthesia, and prior to surgery.

Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.

Procedure: High-Resolution Microendoscopy

Undergo evaluation of oral lesions using a high-resolution microendoscope

Other Name: HRME

Procedure: Multispectral Imaging

Undergo evaluation of oral cavity using a widefield multispectral imaging

Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine. [ Time Frame: 1 day ]

Images obtained will be compared against the histology slides of tissue taken from the same region.

Classification of tissue [ Time Frame: 1 day ]

Classification algorithms will be developed to separate imaged tissue into 2 diagnostic categories: normal non-neoplastic mucosa vs. dysplasia and cancer

Secondary Outcome Measures :

Percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye [ Time Frame: 1 day ]

The data analysis will be descriptive and exploratory in nature. The potential association between sites within the same subject will be examined as well. Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.

Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions [ Time Frame: 1 day ]

Performance will be characterized in terms of sensitivity, specificity, area under the ROC curve, and classification accuracy within each diagnostic category.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head & neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible

Ability to understand and the willingness to sign a written informed consent document (ICD)

Exclusion Criteria:

Known allergy to proflavine or acriflavine

Pregnant or nursing females

The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol